CLASSIFICATIONS & STANDARDS

CLASSIFICATIONS & STANDARDS

CLEANROOM CLASSIFICATIONS

Depending on what industry you’re in, and what you’re manufacturing, your cleanroom will have to comply with certain standards. The rooms themselves can be touchy, and everything you bring into the cleanroom is likely to release particles into the air, even your employees. But how do you know what classification your cleanroom has to fit into, and how do you know what equipment you need to meet that classification? Once you determine the answers to these questions, it’ll be much easier to figure out what type of cleanroom you need, and how much contamination you’ll have to control.

QUICK TIP...

Did you know Angstrom Technology can provide maintenance for your cleanrooms? We’ll make sure you have the right supplies and testing equipment to keep your cleanroom up to standards at all times.

CLEANROOM CLASSIFICATIONS

Depending on what industry you’re in, and what you’re manufacturing, your cleanroom will have to comply with certain standards. The rooms themselves can be touchy, and everything you bring into the cleanroom is likely to release particles into the air, even your employees. But how do you know what classification your cleanroom has to fit into, and how do you know what equipment you need to meet that classification? Once you determine the answers to these questions, it’ll be much easier to figure out what type of cleanroom you need, and how much contamination you’ll have to control.

QUICK TIP...

Did you know Angstrom Technology can provide maintenance for your cleanrooms? We’ll make sure you have the right supplies and testing equipment to keep your cleanroom up to standards at all times.

DETERMINING CONTAMINATION

If your industry doesn’t have a default classification, or if you think that you might want more contamination control than what is recommended, there’s three basic questions you can ask to determine what standard you’ll have to comply with:

DETERMINING CONTAMINATION

If your industry doesn’t have a default classification, or if you think that you might want more contamination control than what is recommended, there’s three basic questions you can ask to determine what standard you’ll have to comply with:

WHAT ARE YOUR SOURCES OF CONTAMINATION?

Where do particles get in, and how do they get in?

WHAT SIZE PARTICLES DO YOU NEED TO FILTER OUT?

What particles adversely affect your operation?

HOW MUCH CIRCULATING AIR WILL YOU NEED, TO GET RID OF THAT CONTAMINATION?

What class is your cleanroom?

SOURCES OF CONTAMINATION

The point of a cleanroom is to keep the outside from getting in. Once you install a cleanroom, theoretically if no one entered or left, and you changed filters regularly, it would perform to exactly the standards it was set up to. Unfortunately, the world doesn’t function in a vacuum, and you do need employees to go in and out if you want to get anything accomplished. So what are your main sources of contamination, and how do you make sure they don’t disrupt your cleanroom classifications?

EMPLOYEES

Your biggest source of contamination is going to be your employees. Humans regularly shed particles of all kinds, from hair to dead skin, and there’s no real way to stop that from happening. So, any employee that enters a cleanroom will be required to wear a certain amount of protective clothing. Each cleanroom environment will have standardized gowning procedures to make sure that the right amount of particles are kept from contaminating your cleanroom.

THE PROCESS

The other source of contamination is the process. This means the cleanroom itself. You have to know where trouble areas might be in the cleanroom, and if it’s potentially letting in any type of contamination. Once you know where the trouble areas are, you can place return air grill and filtration systems at the optimal locations within your cleanroom, ensuring that your cleanroom functions to its highest capacity.

SOURCES OF CONTAMINATION

The point of a cleanroom is to keep the outside from getting in. Once you install a cleanroom, theoretically if no one entered or left, and you changed filters regularly, it would perform to exactly the standards it was set up to. Unfortunately, the world doesn’t function in a vacuum, and you do need employees to go in and out if you want to get anything accomplished. So what are your main sources of contamination, and how do you make sure they don’t disrupt your cleanroom classifications?

EMPLOYEES

Your biggest source of contamination is going to be your employees. Humans regularly shed particles of all kinds, from hair to dead skin, and there’s no real way to stop that from happening. So, any employee that enters a cleanroom will be required to wear a certain amount of protective clothing. Each cleanroom environment will have standardized gowning procedures to make sure that the right amount of particles are kept from contaminating your cleanroom.

THE PROCESS

The other source of contamination is the process. This means the cleanroom itself. You have to know where trouble areas might be in the cleanroom, and if it’s potentially letting in any type of contamination. Once you know where the trouble areas are, you can place return air grill and filtration systems at the optimal locations within your cleanroom, ensuring that your cleanroom functions to its highest capacity.

WHAT PARTICLE SIZE HAS TO DO WITH YOUR CLASSIFICATION

It’s important to know what specific types of particles you need to filter out. Classifications vary based on both how many particles are allowed per square foot, but also by the size of the particles. 10 particles that are ½ micron in size is a much different amount of contamination than 10 particles that are 5 microns in size. Usually, your industry will specify what size particles are damaging to your product or your process, and will say how many are allowed per square foot for you to be in compliance. You have to factor in both particle size, and the amount of particles allowed to define the right contamination class for your cleanroom.

WHAT PARTICLE SIZE HAS TO DO WITH YOUR CLASSIFICATION

It’s important to know what specific types of particles you need to filter out. Classifications vary based on both how many particles are allowed per square foot, but also by the size of the particles. 10 particles that are ½ micron in size is a much different amount of contamination than 10 particles that are 5 microns in size. Usually, your industry will specify what size particles are damaging to your product or your process, and will say how many are allowed per square foot for you to be in compliance. You have to factor in both particle size, and the amount of particles allowed to define the right contamination class for your cleanroom.

AIR CIRCULATION & CLASSIFICATION

Air circulation is very important to maintaining a proper cleanroom. Each class of cleanroom will have a certain amount of required air based on the size of the cleanroom, and the bigger your space, the more air you’ll have to pump in. Believe it or not, each time you go up a class, say from an ISO 8 to an ISO 7, you’ll have to use twice as much air. That’s why you really want to think about the construction of your cleanroom, and you’ll need to talk to your contractor to make sure you’re creating the most efficient cleanroom possible.

For example, the building you’re using to install your cleanroom has 10 foot ceilings. You’d like to use your existing ceilings for the ceiling of your cleanroom, but consider that by having 10 foot ceilings, instead of 8 foot ceilings, you’re increasing the space in the room by 25%. That means you’ll have to pump in 25% more air to keep that cleanroom clean. So, make sure you’ve thought about all of your options, and you work closely with your contractor before you make a final decision.

AIR CIRCULATION & CLASSIFICATION

Air circulation is very important to maintaining a proper cleanroom. Each class of cleanroom will have a certain amount of required air based on the size of the cleanroom, and the bigger your space, the more air you’ll have to pump in. Believe it or not, each time you go up a class, say from an ISO 8 to an ISO 7, you’ll have to use twice as much air. That’s why you really want to think about the construction of your cleanroom, and you’ll need to talk to your contractor to make sure you’re creating the most efficient cleanroom possible.

For example, the building you’re using to install your cleanroom has 10 foot ceilings. You’d like to use your existing ceilings for the ceiling of your cleanroom, but consider that by having 10 foot ceilings, instead of 8 foot ceilings, you’re increasing the space in the room by 25%. That means you’ll have to pump in 25% more air to keep that cleanroom clean. So, make sure you’ve thought about all of your options, and you work closely with your contractor before you make a final decision.

CLEANROOM SPECIFICATIONS

While it’s our job to make sure that your cleanroom functions exactly to your specifications, it’s good for you to know what those specifications are. For instance, the default standard for medical device packaging is ISO 7 (a class 10,000 cleanroom). See the chart below for more information on classes.

CLEANROOM SPECIFICATIONS

While it’s our job to make sure that your cleanroom functions exactly to your specifications, it’s good for you to know what those specifications are. For instance, the default standard for medical device packaging is ISO 7 (a class 10,000 cleanroom). See the chart below for more information on classes.

STANDARD CLASSIFICATIONS

Maximum number of particles in the air

ISO RECOMMENDED AIR CHANGE RATES

Recommended air changes and ceiling coverage

STANDARD CLASSIFICATIONS

Maximum number of particles in the air

ISO RECOMMENDED AIR CHANGE RATES

Recommended air changes and ceiling coverage

ISO RECOMMENDED AIR CHANGE RATES

Another important aspect of contamination control in your cleanroom is the air-change per hour (ACH), also referred to as the air-change rate (ACR). This refers to the amount of times per hour that the air inside your cleanroom is exchanged for new, filtered outside air. For reference, a normal home with an air conditioner changes room air a maximum of twice an hour, while a cleanroom can change air anywhere from 10 to over 600 times an hour. The chart shows the range of air change and the ceiling coverage recommended based on the ISO class of your cleanroom.

ISO CLASS

AIR CHANGES PER HOUR

CEILING COVERAGE

ISO 1

500 – 750

80 – 100%

ISO 2

500 – 750

80 – 100%

ISO 3

500 – 750

60 – 100%

ISO 4

400 – 750

50 – 90%

ISO 5

240 – 600

35 – 70%

ISO 6

150 – 240

25 – 40%

ISO 7

60 – 150

15 – 25%

ISO 8

6 – 60

5 – 15%

STANDARD CLASSIFICATIONS

Classifications are generally recognized on two different scales. First, the International Standards Organization (ISO), and second, the U.S. General Service Administration’s standards, scientifically known as FS209E, and colloquially referred to as Classes. We’ve included a chart to show what the specific requirements are for each standard, based on both the amount of particles, and particle size. Note that both ISO and FS209E Classes overlap.